Profilaxis antiemética en pacientes con neoplasias hematológicas que reciben protocolos de acondicionamiento para el trasplante de células madre hematopoyéticas: protocolo de estudio para una revisión sistemática / Antiemetic prophylaxis in hematologic malignancies patients receiving conditioning protocols for hematopoietic stem cell transplantation: A study protocol for a systematic review

Objetivo las náuseas y los vómitos inducidos por la quimioterapia siguen siendo un reto importante para los pacientes que recibieron un trasplante de células madre hematopoyéticas. Este estudio tiene como objetivo sintetizar la evidencia disponible sobre los regímenes de profilaxis antiemética en los pacientes con neoplasias hematológicas que recibieron un trasplante de células madre hematopoyéticas, con el fin de identificar el mejor estándar de cuidado. Métodos se llevará a cabo una revisión sistemática utilizando las bases de datos MEDLINE a través de PubMed, EMBASE, Clinical-Trials.gov y Cochrane. Se considerarán los estudios escritos en inglés, francés, italiano o español. Después de seleccionar los estudios de acuerdo con los criterios de inclusión y exclusión, 2 revisores independientes extraerán los datos y evaluarán el riesgo de sesgo en los artículos seleccionados. Este protocolo se ha elaborado de acuerdo con las recomendaciones de las guías PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols). Este protocolo está registrado en PROSPERO (Prospective Register of Ongoing Systematic Reviews) CRD42023406380. Discusión las náuseas y los vómitos inducidos por la quimioterapia son un efecto secundario incapacitante que supone un reto importante para los pacientes con neoplasias hematológicas. A pesar de la publicación de diversas guías sobre profilaxis antiemética, ninguna de ellas incluye recomendaciones específicas para cada régimen de quimioterapia. Por lo tanto, analizar los regímenes de profilaxis antiemética primaria en los pacientes con neoplasias hematológicas que recibieron un trasplante de progenitores hematopoyéticos sería valioso para mejorar la calidad de vida de estos pacientes. (AU)

Objective Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. Methods A systematic review will be conducted using MEDLINE via PubMed, EMBASE, ClinicalTrials.gov., and Cochrane databases. Studies written in English, French, Italian or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, two independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. Discussion Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them includes specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life. (AU)

Antiemetic prophylaxis in hematologic malignancies patients receiving conditioning protocols for hematopoietic stem cell transplantation: A study protocol for a systematic review. / [Artículo traducido] Profilaxis antiemética en pacientes con neoplasias hematológicas que reciben protocolos de acondicionamiento para el trasplante de células madre hematopoyéticas: protocolo de estudio para una revisión sistemática.

OBJECTIVE: Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. METHODS: A systematic review will be conducted using MEDLINE via PubMed, EMBASE, ClinicalTrials.gov., and Cochrane databases. Studies written in English, French, Italian or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, two independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. DISCUSSION: Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them includes specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life.

Combined or Sequential Treatment with Immune Checkpoint Inhibitors and Car-T Cell Therapies for the Management of Haematological Malignancies: A Systematic Review.

The aim of this paper was to review the available evidence on the efficacy and safety of combined or sequential use of PD-1/PD-L1 immune checkpoint inhibitors (ICI) and CAR-T cell therapies in relapsed/refractory (R/R) haematological malignancies. A systematic literature review was performed until 21 November 2022. Inclusion criteria: cohort studies/clinical trials aimed at evaluating the efficacy and/or safety of the combination of CAR-T cell therapy with PD-1/PD-L1 inhibitors in R/R haematological malignancies, which had reported results. Those focusing only on ICI or CAR-T separately or evaluating the combination in other non-hematological solid tumours were excluded. We used a specific checklist for quality assessment of the studies, and then we extracted data on efficacy or efficiency and safety. A total of 1867 articles were identified, and 9 articles were finally included (early phase studies, with small samples of patients and acceptable quality). The main pathologies were B-cell acute lymphoblastic leukaemia (B-ALL) and B-cell non-Hodgkin's lymphoma (B-NHL). The most studied combination was tisagenlecleucel with pembrolizumab. In terms of efficacy, there is great variability: the combination could be a promising option in B-ALL, with modest data, and in B-NHL, although hopeful responses were received, the combination does not appear better than CAR-T cell monotherapy. The safety profile could be considered comparable to that described for CAR-T cell monotherapy.

Antiemetic prophylaxis in hematologic malignancies patients receiving conditioning protocols for hematopoietic stem cell transplantation: A study protocol for a systematic review.

OBJECTIVE: Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. METHODS: A systematic review will be conducted using MEDLINE via PubMed, EMBASE, Clinical-Trials.gov., and Cochrane databases. Studies written in English, French, Italian, or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, 2 independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. DISCUSSION: Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them include specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life.

Influence of Performance Status on the Effectiveness of Pembrolizumab Monotherapy in First-Line for Advanced Non-Small-Cell Lung Cancer: Results in a Real-World Population.

The KEYNOTE-024 clinical trial showed promising results for pembrolizumab in the first-line of treatment of advanced non-small-cell lung cancer (NSCLC). However, the profile of patients in real-world practice differs from those included in this clinical trial. Here, an observational single-center retrospective study was performed through a comparative analysis of clinical outcomes after pembrolizumab therapy according to the Eastern Cooperative Oncology Group Stage Performance Status (ECOG PS). Moreover, univariate and multivariate analyses were carried out to detect prognostic factors. In our cohort, 63.7% of patients had an ECOG PS of 0-1. Regarding response rate, 31.8% of patients had a partial response (PR), 19.3% had stable disease (SD) and 23.9% had progression disease. On the other hand, patients with ECOG PS ≥ 2 showed a significantly lower rate of PR and SD to pembrolizumab than patients with a PS of 0-1. The rate of response, median overall survival (OS) and progression-free survival (PFS) were significantly higher in patients with ECOG PS 0-1 than in those with ECOG PS ≥ 2. In the current study, we found ECOG PS as the only independent predictor of OS and PFS. Due to the ECOG PS scale being a subjective parameter, other tools are needed to identify treatment effectiveness to each patient.

Efficacy and safety of a comprehensive educational antimicrobial stewardship program focused on antifungal use.

OBJECTIVE: Few data exist regarding the impact of antimicrobial stewardship programs on antifungal use. We evaluated the efficacy and safety of a comprehensive long-term antimicrobial stewardship program (ASP) focused on antifungal use. METHODS: During a 9-year period, we quarterly assessed antifungal consumption, incidence density of hospital-acquired candidemia, Candida spp. distribution, antifungal resistance, and crude death rate per 1000 occupied bed days (OBDs) of hospital-acquired candidemia. We performed segmented regression analysis of interrupted time series. RESULTS: A significant change in trend was observed for antifungal consumption, with a sustained reduction of -0.87% per quarter (95% confidence interval [CI], -1.36 -0.38, p < 0.001), accounting for a final reduction of -38.4%. The main reduction was produced in fluconazole, with a sustained reduction of -1.37% per quarter (95%CI, -1.96 -0.68, p<0.001). The incidence density of hospital-acquired candidemia decreased, with a change in slope of -5.06% cases per 1000 OBDs per year (95%CI, -8.23 -1.77, p = 0.009). The 14-day crude death rate per 1000 OBDs dropped from 0.044 to 0.017 (-6.36% deaths per 1000 OBDs per year; 95%CI, -13.45 -1.31, p = 0.09). CONCLUSIONS: This ASP has succeeded in optimizing the use of antifungal with a long-lasting reduction without increasing the incidence, neither the mortality, of hospital-acquired candidemia.

Clinical impact of an educational antimicrobial stewardship program associated with infectious diseases consultation targeting patients with cancer: Results of a 9-year quasi-experimental study with an interrupted time-series analysis.

OBJECTIVES: Antibiotic stewardship programs (ASP) have already demonstrated clinical benefits. However, their effectiveness or safety in immunocompromised hosts needs to be proved. METHODS: An ecologic quasi-experimental study was performed from January 2009 to June 2017 in the Oncology department of a tertiary-care hospital. A stable program of Infectious Diseases consultation (IDC) already existed at this unit, and an educational ASP was added in 2011. Its main intervention consisted of face-to-face educational interviews. Antibiotic consumption was assessed through quarterly Defined Daily Doses (DDD) per 100 occupied bed-days. Mortality was evaluated in patients with bloodstream infections through the quarterly incidence density per 1000 admissions, and the annual mortality rates at 7 and 30-days. Time-trends were analysed through segmented-regression analysis, and the impact of the ASP was assessed through before-after interrupted time-series analysis. RESULTS: Mortality significantly decreased throughout the study period (-13.3% annual reduction for 7-day mortality rate, p < 0.01; -8.1% annual reduction for 30-day mortality, p = 0.03), parallel to a reduction in antibiotic consumption (quarterly reduction -0.4%, p = 0.01), especially for broader-spectrum antibiotics. The before-after study settled a significant inflexion point on the ASP implementation for the reduction of antibiotic consumption (change in level 0.95 DDD, p = 0.71; change in slope -1.98 DDD per quarter, p < 0.01). The decreasing trend for mortality before the ASP also continued after its implementation. CONCLUSIONS: The combination of an ASP with IDC improved antibiotic use among patients with cancer, and was accompanied by a reduction of mortality of bacteraemic infections. Implementation of the ASP was necessary to effectively change antibiotic use.

Evaluation of the impact of a nationwide massive online open course on the appropriate use of antimicrobials.

Objectives: To evaluate the impact of a massive online open course (MOOC) design on the appropriate use of antimicrobial agents, to determine specific study areas with better learning outcomes and to identify weak points. Methods: A pre- and post-intervention study in the context of a training course on infectious diseases aimed at health professionals. We designed a questionnaire with 30 questions related to the management of infectious diseases in different clinical situations. Participants had to answer the questions based on their competencies and training for these situations. We analysed the scores obtained before and after the course and the resulting progress. In addition, an open response section was provided to enable a qualitative evaluation. Results: Two thousand one hundred and forty-eight health professionals were enrolled in the course. The questionnaire was completed before and after the course by 606 participants, mainly physicians (81.2%) and pharmacists (15.4%). The mean overall scores for the pre- and post-course questionnaires were 6.2 (SD 1.38) and 7.9 (SD 0.88), respectively (overall score increase = 1.8, SD 1.21, P < 0.001). A significant increase in self-assessment was detected (P < 0.001) for all the questions. Qualitative assessments were provided by 218 participants with 225 comments, most of which were very positive. Conclusions: The course with a MOOC design showed a great teaching capacity in the infectious diseases area for all the clinical situations analysed, notably in the management of severe infections with higher mortality. For future editions of this training activity, the need to include other infectious diseases, especially infections in primary care, was highlighted.

Systematic review of the efficacy of statins for the treatment of Alzheimer's disease.

Alzheimer's disease (AD) is the most common type of dementia. Recent studies have assessed the possibility of using statins as treatment for AD. However, their efficacy is not clear. In this study, we collected the most relevant information about the efficacy of statins for the treatment of AD. We conducted a systematic literature search using MEDLINE, EMBASE and The Cochrane Library. We included clinical trials, meta-analyses and systematic reviews that analysed the efficacy of statins in AD. We also extracted the characteristics and efficacy results of the studies selected. Of the 304 articles identified, 13 complied with the inclusion criteria. The scientific quality of studies was high and their results indicated that there were no significant differences in the main efficacy variables between statins and placebo treatment for AD. Therefore, according to the available scientific evidence, statins have not shown an improvement in cognition and do not appear to offer significant benefits to patients with AD.

The role of clinical pharmacists in the optimisation of medication prescription and reconciliation on admission in an emergency department.

OBJECTIVES: To describe a clinical pharmacist's (CP) activity in an emergency department (ED) regarding medication reconciliation and optimisation of pharmacotherapy of patients at hospital admission. METHODS: A 1-year prospective observational study was conducted to analyse the activity of a CP in the ED of a 350-bed hospital in Spain. The CP reviewed home medications and medical prescriptions of patients to perform medication reconciliation if required and intervene if medication errors were detected. RESULTS: The CP reviewed medications and medical orders of 1048 patients. 816 patients had home medication: 440 patients (53.9%) were correctly reconciled by the physician; 136 (16.7%) were reconciled by the physician with unintentional discrepancies; and 240 (29.4%) by the CP, with a higher percentage in patients admitted to surgical departments (χ2:38.698; P<0.001). Following pharmaceutical validation, 434 pharmaceutical interventions were performed. CONCLUSIONS: The presence of a CP in an ED could increase the detection of reconciliation errors and help resolve medication errors.

Clinical relevance of pharmacist intervention in an emergency department.

OBJECTIVES: To evaluate the clinical relevance of pharmacist intervention on patient care in emergencies, to determine the severity of detected errors. Second, to analyse the most frequent types of interventions and type of drugs involved and to evaluate the clinical pharmacist's activity. METHODS: A 6-month observational prospective study of pharmacist intervention in the Emergency Department (ED) at a 400-bed hospital in Spain was performed to record interventions carried out by the clinical pharmacists. We determined whether the intervention occurred in the process of medication reconciliation or another activity, and whether the drug involved belonged to the High-Alert Medications Institute for Safe Medication Practices (ISMP) list. To evaluate the severity of the errors detected and clinical relevance of the pharmacist intervention, a modified assessment scale of Overhage and Lukes was used. Relationship between clinical relevance of pharmacist intervention and the severity of medication errors was assessed using ORs and Spearman's correlation coefficient. RESULTS: During the observation period, pharmacists reviewed the pharmacotherapy history and medication orders of 2984 patients. A total of 991 interventions were recorded in 557 patients; 67.2% of the errors were detected during medication reconciliation. Medication errors were considered severe in 57.2% of cases and 64.9% of pharmacist intervention were considered relevant. About 10.9% of the drugs involved are in the High-Alert Medications ISMP list. The severity of the medication error and the clinical significance of the pharmacist intervention were correlated (Spearman's ρ=0.728/p<0.001). CONCLUSIONS: In this single centre study, the clinical pharmacists identified and intervened on a high number of severe medication errors. This suggests that emergency services will benefit from pharmacist-provided drug therapy services.

Effectiveness and safety of pemetrexed for non-small cell lung cancer in the Andalusian Public Health System / Efectividad y seguridad del pemetrexed en el cáncer de pulmón no microcítico en el Sistema Sanitario Público de Andalucía

Objective: To evaluate effectiveness and safety profile of pemetrexed in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) when it's used on real clinical practice in Andalusia (a Spanish region with 8.5 million inhabitants, 2014 census data). Methods: An observational multicentre retrospective study was conducted. Adult patients with locally advanced/metastatic NSCLC who received pemetrexed in any hospital in the Andalusian Public Health System during the last term of 2011 were included. We collected patients' baseline characteristics, diagnostic and treatment data, effectiveness variables (response to treatment with pemetrexed and overallsurvival) and main adverse reactions detected. Results: 172 patients from 17 hospitals were included (77.33% were men), median age 63 years old (between 34 and 83). The predominant histology was adenocarcinoma (84.30%) and 85.20% were diagnosed of lung cancer with IV-stage. 78.49% had been smokers at some point in their lives. Median overall survival from the start of pemetrexed was 9 months (95%CI, 4.1-13.9). Progression of the disease was the most frequent response (33.14%), only one patient had complete response. Stable disease was associated with a higher probability of survival. Main adverse reactions detected were asthenia, haematological reactions, gastrointestinal reactions and dermal o mucous toxicity. No patients discontinued treatment for serious toxicity. Conclusions: Pemetrexed resulted quite effective in NSCLC when it was used on real clinical practice, with higher survival in non-squamous histology and patients with the best score of Eastern Cooperative Oncology Group scale. The toxicity profile was well tolerated. Prospective studies would be needed to confirm the effect of prognostic factors observed (AU)

Objetivo: Evaluar la efectividad y el perfil de seguridad del pemetrexed en pacientes con cáncer de pulmón no microcítico (CPNM) localmente avanzado o metastásico en la práctica clínica real en Andalucía (una región española con 8,5 millones de habitantes según los datos del censo de 2014). Métodos: Se realizó un estudio retrospectivo multicéntrico observacional, incluyendo aquellos pacientes adultos con CPNM localmente avanzado/metastásico que hubiesen recibido pemetrexed en cualquier hospital del Sistema Sanitario Público de Andalucía durante el último trimestre de 2011. Se revisaron las características basales de los pacientes, los datos relativos al diagnóstico y al tratamiento, las variables de efectividad (en términos de respuesta al tratamiento con pemetrexed y supervivencia global) y las principales reacciones adversas detectadas. Resultados: Se incluyeron un total de 172 pacientes procedentes de 17 hospitales (77,33% hombres), con una mediana de edad de 63 años (rango: 34 y 83). La histología predominante fue el adenocarcinoma (84,30%) y el 85,20% fueron diagnosticados de cáncer de pulmón en estadio IV. El 78,49% habían sido fumadores en algún momento de sus vidas. La mediana de supervivencia global desde el inicio del pemetrexed fue de 9 meses (IC del 95%, 4,1-13,9). La progresión de la enfermedad fue la respuesta al tratamiento más frecuente (33,14%) y solo un paciente tuvo una respuesta completa. La presencia de enfermedad estable se asoció con una mayor probabilidad de supervivencia. Las principales reacciones adversas detectadas fueron astenia; reacciones hematológicas, gastrointestinales y dermatológicas o toxicidad mucosa. Ninguno de los pacientes interrumpió el tratamiento por toxicidad grave. Conclusiones: El pemetrexed resultó bastante efectivo en el CPNM cuando fue utilizado en la práctica clínica real, con una mayor supervivencia en histología no escamosa y en los pacientes con mejor puntuación en la escala Eastern Cooperative Oncology Group. El perfil de toxicidad fue bien tolerado. Serían necesarios estudios prospectivos para confirmar el efecto de los factores pronósticos observados (AU)

Effectiveness and safety of pemetrexed for non-small cell lung cancer in the Andalusian Public Health System.

OBJECTIVE: To evaluate effectiveness and safety profile of pemetrexed in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) when it´s used on real clinical practice in Andalusia (a Spanish region with 8.5 million inhabitants, 2014 census data). METHODS: An observational multicentre retrospective study was conducted. Adult patients with locally advanced/metastatic NSCLC who received pemetrexed in any hospital in the Andalusian Public Health System during the last term of 2011 were included. We collected patients´ baseline characteristics, diagnostic and treatment data, effectiveness variables (response to treatment with pemetrexed and overallsurvival) and main adverse reactions detected. RESULTS: 172 patients from 17 hospitals were included (77.33% were men), median age 63 years old (between 34 and 83). The predominant histology was adenocarcinoma (84.30%) and 85.20% were diagnosed of lung cancer with IV-stage. 78.49% had been smokers at some point in their lives. Median overall survival from the start of pemetrexed was 9 months (95%CI, 4.1-13.9). Progression of the disease was the most frequent response (33.14%), only one patient had complete response. Stable disease was associated with a higher probability of survival. Main adverse reactions detected were asthenia, haematological reactions, gastrointestinal reactions and dermal o mucous toxicity. No patients discontinued treatment for serious toxicity. CONCLUSIONS: Pemetrexed resulted quite effective in NSCLC when it was used on real clinical practice, with higher survival in non-squamous histology and patients with the best score of Eastern Cooperative Oncology Group scale. The toxicity profile was well tolerated. Prospective studies would be needed to confirm the effect of prognostic factors observed.

Objetivo: Evaluar la efectividad y el perfil de seguridad del pemetrexed en pacientes con cáncer de pulmón no microcítico (CPNM) localmente avanzado o metastásico en la práctica clínica real en Andalucía (una región española con 8,5 millones de habitantes según los datos del censo de 2014). Métodos: Se realizó un estudio retrospectivo multicéntrico observacional, incluyendo aquellos pacientes adultos con CPNM localmente avanzado/metastásico que hubiesen recibido pemetrexed en cualquier hospital del Sistema Sanitario Público de Andalucía durante el último trimestre de 2011. Se revisaron las características basales de los pacientes, los datos relativos al diagnóstico y al tratamiento, las variables de efectividad (en términos de respuesta al tratamiento con pemetrexed y supervivencia global) y las principales reacciones adversas detectadas. Resultados: Se incluyeron un total de 172 pacientes procedentes de 17 hospitales (77,33% hombres), con una mediana de edad de 63 años (rango: 34 y 83). La histología predominante fue el adenocarcinoma (84,30%) y el 85,20% fueron diagnosticados de cáncer de pulmón en estadio IV. El 78,49% habían sido fumadores en algún momento de sus vidas. La mediana de supervivencia global desde el inicio del pemetrexed fue de 9 meses (IC del 95%, 4,1-13,9). La progresión de la enfermedad fue la respuesta al tratamiento más frecuente (33,14%) y solo un paciente tuvo una respuesta completa. La presencia de enfermedad estable se asoció con una mayor probabilidad de supervivencia. Las principales reacciones adversas detectadas fueron astenia; reacciones hematológicas, gastrointestinales y dermatológicas o toxicidad mucosa. Ninguno de los pacientes interrumpió el tratamiento por toxicidad grave. Conclusiones: El pemetrexed resultó bastante efectivo en el CPNM cuando fue utilizado en la práctica clínica real, con una mayor supervivencia en histología no escamosa y en los pacientes con mejor puntuación en la escala Eastern Cooperative Oncology Group. El perfil de toxicidad fue bien tolerado. Serían necesarios estudios prospectivos para confirmar el efecto de los factores pronósticos observados.

[Analysis of the concordance of antibiotic treatment for patients with severe sepsis in emergencies]. / Análisis de la concordancia del tratamiento antibiótico de pacientes con sepsis grave en Urgencias.

OBJECTIVES: Antibiotic treatment is vital in patients with severe sepsis/septic shock. The objectives were to assess the degree of concordance between antibiotic prescribed in emergencies and post requirements; to relate it to health outcomes (mortality) and to analyze the reasons for disagreement. MATERIAL AND METHODS: Retrospective descriptive study of antibiotic treatment prescribed in emergencies and the subsequent treatment in patients with criteria of severe sepsis/septic shock in 2013. We collected patient demographic characteristics, infectious focus, antibiotic prescribed from emergencies and subsequent changes. It was considered concordant if there were no changes, if there were changes, but the initial antibiotic was right and suspensions for end of treatment. Mortality and evolution were analyzed. RESULTS: Six hundred patients were included. A 60% experienced changes respect to the antibiotic treatment initiated in emergencies (87.6% justified), with a degree of overall antibiotic concordance of 47.5% The mortality rate at end-point was 9.83%, with no statistically significant relationship with the degree of concordance (OR=0.864 (0.503-1.484)/χ2=0.28; p=0.597). Reasons for change of antibiotic: clinical outcome (17.96%), change of spectrum (35.03%), de-escalation (41.32%), sequential therapy (8.68%). An 11% required ICU admission. Clinical outcomes: resolution of the disease (79.2%), readmission after 30 days (7.7%) and transfer to health centers (4.5%). The median hospital stay was 7 days. CONCLUSIONS: The degree of concordance antibiotic was quite high, and the mortality rate was lower than that described in the literature, without relating to the discordance. The presence of concordance was associated with fewer readmissions and ICU admissions. The main reasons for disagreement were inadequate spectrum selection and change after microbiological crops.

Análisis de la concordancia del tratamiento antibiótico de pacientes con sepsis grave en Urgencias / Analysis of the concordance of antibiotic treatment for patients with severe sepsis in emergencies

Objetivos. El tratamiento antibiótico resulta de vital importancia en pacientes con sepsis grave/shock séptico. Los objetivos fueron evaluar el grado de concordancia entre la prescripción de antibióticos realizada en urgencias y prescripciones posteriores; relacionarlo con resultados en salud (mortalidad) y analizar los motivos de discordancia. Material y métodos. Estudio descriptivo retrospectivo del tratamiento antibiótico prescrito desde urgencias y el prescrito posteriormente en pacientes con criterios de sepsis grave/shock séptico en el año 2013. Se recogieron características demográficas, foco infeccioso, antibiótico prescrito desde urgencias y los cambios posteriores, considerándose concordante cuando no había cambio, si había cambio pero el antibiótico inicial era correcto y suspensiones por fin de tratamiento. Se analizó mortalidad y evolución del cuadro. Resultados. Se incluyeron 600 pacientes. El 60% sufrió cambio de tratamiento antibiótico respecto al iniciado en urgencias (87,6% justificados), con un grado de concordancia antibiótica global del 47,5%. La tasa de mortalidad al final del estudio fue 9,83%, no encontrándose relación estadísticamente significativa con el grado de concordancia (OR=0,864 (0,503-1,484)/X2=0,28, p=0,597). Motivos de cambio de antibiótico: evolución clínica (17,96%), cambio de espectro (35,03%), desescalada (41,32%), terapia secuencial (8,68%). El 11% requirió ingreso en Unidad de Cuidados Intensivos (UCI). Evoluciones clínicas: resolución del cuadro (79,2%), reingreso antes de 30 días (7,7%) y traslado a centros sociosanitarios (4,5%). La mediana de estancia hospitalaria fue 7 días. Conclusiones. El grado de concordancia antibiótica resultó bastante alto y la tasa de mortalidad inferior a la descrita en la literatura, sin relacionarse con la discordancia. La presencia de concordancia se asoció a menos reingresos e ingresos en UCI. Los principales motivos de discordancia fueron selección del espectro inadecuado y el cambio tras cultivos microbiológicos (AU)

Objectives. Antibiotic treatment is vital in patients with severe sepsis/septic shock. The objectives were to assess the degree of concordance between antibiotic prescribed in emergencies and post requirements; to relate it to health outcomes (mortality) and to analyze the reasons for disagreement. Material and methods. Retrospective descriptive study of antibiotic treatment prescribed in emergencies and the subsequent treatment in patients with criteria of severe sepsis/septic shock in 2013. We collected patient demographic characteristics, infectious focus, antibiotic prescribed from emergencies and subsequent changes. It was considered concordant if there were no changes, if there were changes, but the initial antibiotic was right and suspensions for end of treatment. Mortality and evolution were analyzed. Results. Six hundred patients were included. A 60% experienced changes respect to the antibiotic treatment initiated in emergencies (87.6% justified), with a degree of overall antibiotic concordance of 47.5% The mortality rate at endpoint was 9.83%, with no statistically significant relationship with the degree of concordance (OR=0.864 (0.503-1.484)/χ2=0.28; p=0.597). Reasons for change of antibiotic: clinical outcome (17.96%), change of spectrum (35.03%), de-escalation (41.32%), sequential therapy (8.68%). An 11% required ICU admission. Clinical outcomes: resolution of the disease (79.2%), readmission after 30 days (7.7%) and transfer to health centers (4.5%). The median hospital stay was 7 days. Conclusions. The degree of concordance antibiotic was quite high, and the mortality rate was lower than that described in the literature, without relating to the discordance. The presence of concordance was associated with fewer readmissions and ICU admissions. The main reasons for disagreement were inadequate spectrum selection and change after microbiological crops (AU)

Use of pemetrexed for non-small cell lung cancer in the Andalusian public health system.

The aim of this study is to determine the profile of the use of pemetrexed in metastatic or locally advanced NSCLC in Andalusia and its variation over 2 years (2010-2011). A prescription-indication observational retrospective multicenter study was conducted. Adult patients with locally advanced/metastatic NSCLC who received pemetrexed in any hospital in the Andalusian Public Health System during the first term of 2010 or the last term of 2011 were included. We collected patients' baseline characteristics, tumour histology and stage, pemetrexed indication and performance status at the start of treatment. In all, 107 and 170 patients (62 ± 11 years old) from 17 hospitals were included in 2010 and 2011, respectively. The predominant histology was adenocarcinoma (85%), 88% of patients had stage IV tumours and 52% Eastern Cooperative Oncology Group stage (ECOG) 1. Pemetrexed indications in 2010 and 2011 were: First line combined with platinum (28.97-37.64%); first line combined with platinum and maintenance with pemetrexed (24.30-28.82%); second line mono-therapy (12.15-7.65%) and maintenance (2.15-7.05%). Off-label use was detected in 22.43% (2010) and 18.84% (2011). In conclusion, pemetrexed combined with platinum is mainly used as first-line treatment in NSCLC patients with stage IV, adenocarcinoma histologic subtype and good performance status. Off-label use is high (especially in 2010). An adequate therapeutic positioning for pemetrexed based on effectiveness and safety analysis should be defined, so that NSCLC patients could be beneficiated with the most cost-effective chemotherapy treatment.

Systematic review of efficacy and safety of pemetrexed in non-small-cell-lung cancer.

INTRODUCTION: Lung cancer accounts for 20 % of cancer deaths in Spain. The most frequent subtype (87 %) is non-small cell lung cancer (NSCLC). Pemetrexed is a recently marketed drug added to NSCLC therapeutic arsenal. It seems to have become one of the most used options for the treatment of this condition over the last 3 years. AIM OF THE REVIEW: To evaluate the efficacy and safety of pemetrexed in NSCLC, in the different therapy lines. Method A systematic search of published literature was conducted using the main databases (MEDLINE, EMBASE, the Cochrane Library and the Center for Reviews and Dissemination) and subsequently a search of referenced literature was performed. We included clinical trials, meta-analyses and systematic reviews. The evaluation of the quality of the articles was performed by pairs using specific assessment scales, Critical Appraisal Skills Program (CASP) adapted for CASP Spain. Then we extracted data on efficacy and safety according to the treatment line assessed. RESULTS: We identified 277 references. Finally, nine clinical trials and a meta-analysis complied with inclusion criteria. In first-line induction, treatment with pemetrexed associated with a platinum was similar in terms of efficacy to other alternative chemotherapy regimens, except in patients with non-squamous histology, in whom survival was higher in the experimental group. In maintenance treatment, greater efficacy was seen with pemetrexed in patients with non-squamous histology. In second-line treatment, there were no significant differences in terms of efficacy and safety for pemetrexed treatment versus other chemotherapy options. The most frequent adverse reactions were: hematological, gastrointestinal and neurological. All were significantly less frequent with pemetrexed versus other alternative therapies, except for liver toxicity. CONCLUSIONS: Due to the high degree of uncertainty as to its efficacy in certain subgroups of patients, including conflicting data; to its recent incorporation, and therefore lack of safety data in the medium and long term, and the high budgetary impact of its incorporation into health systems, it seems reasonable to optimize its use, identifying those patients who may benefit most.